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Surgical vs Endovascular Management for Brain Aneurysm (ISAT II Trial)
N/A
Recruiting
Led By Jean Raymond, MD
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients at least 18 years of age
SAH WFNS grade 4 or less
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year and five years
Awards & highlights
ISAT II Trial Summary
This trial is comparing two different ways to fix a burst brain aneurysm in people not previously included in a study.
Who is the study for?
This trial is for adults over 18 with a documented brain aneurysm that has ruptured in the last month. They should be stable enough to undergo surgery or endovascular treatment, as judged by their medical team. People can't join if they're allergic to contrast material used in scans, have aneurysms linked to arteriovenous malformations (AVMs), or if the aneurysm is at the basilar apex.Check my eligibility
What is being tested?
The study aims to compare two treatments for ruptured brain aneurysms: surgical clipping and endovascular coiling. These are different methods of preventing further bleeding from the weakened blood vessel area in the brain.See study design
What are the potential side effects?
Potential side effects may include complications related to surgery such as infection, reaction to anesthesia, stroke, re-bleeding of the aneurysm and neurological deficits. Endovascular treatment risks could involve damage to blood vessels, bleeding or clotting issues.
ISAT II Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My brain hemorrhage is not the most severe grade.
Select...
I had a brain aneurysm rupture in the last 30 days.
ISAT II Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
poor clinical outcome(mRS>2)
Secondary outcome measures
Failure of aneurysm occlusion using the intended treatment modality
Occurence of a "major" (saccular) aneurysm recurrence
Occurence of aneurysm re-rupture following randomization but before treatment initiation
+3 moreISAT II Trial Design
2Treatment groups
Active Control
Group I: Surgical managementActive Control1 Intervention
Surgical clipping will be performed as soon as possible following randomization, according to standards of practice, and under general anesthesia. Aneurysms thought by the treating physicians to require deliberate permanent proximal vessel occlusion, construction of a surgical bypass, or other flow-redirecting treatments that do not directly clip the aneurysm will not be excluded; these non-ISAT aneurysms are expected to be more difficult lesions to manage surgically as well as endovascularly.
Group II: Endovascular managementActive Control1 Intervention
Endovascular treatment will be performed as soon as possible following randomization, according to standards of practice, and under general anesthesia. Details regarding type of coils, use of adjunctive techniques such as balloon-remodeling, stents or flow-diverters, as well as post-treatment medical management issues, will be left up to the physician performing the endovascular treatment.
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Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
366 Previous Clinical Trials
127,913 Total Patients Enrolled
14 Trials studying Aneurysm
3,926 Patients Enrolled for Aneurysm
Jean Raymond, MDPrincipal InvestigatorCentre hospitalier de l'Université de Montréal (CHUM)
9 Previous Clinical Trials
2,591 Total Patients Enrolled
6 Trials studying Aneurysm
1,109 Patients Enrolled for Aneurysm
Tim Darsaut, MDPrincipal InvestigatorUniversity of Alberta
2 Previous Clinical Trials
2,291 Total Patients Enrolled
2 Trials studying Aneurysm
2,291 Patients Enrolled for Aneurysm
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My aneurysm is located at the top part of the basilar artery.I am 18 years old or older.I cannot receive contrast material due to severe allergies or other health reasons.I have aneurysms linked to my AVM condition.My brain hemorrhage is not the most severe grade.My team considers me fit for surgery or a less invasive procedure for my aneurysm.I had a brain aneurysm rupture in the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Surgical management
- Group 2: Endovascular management
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the size of this clinical research cohort?
"1724 qualified participants are necessary for this medical trial to be a success. Participants can join at numerous locations, including Montefiore Medical Center in Bronx, New york and Centre Hospitalier de l'Université de Montréal - Hôpital Notre Dame in Montreal, Quebec."
Answered by AI
Are any individuals currently being enrolled into this research project?
"Correct. According to the information posted on clinicaltrials.gov, this medical study that was first published on November 12th 2012 is actively recruiting participants. 1724 patients need to be enrolled from 3 individual sites in order for the trial to be completed successfully."
Answered by AI
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